Feasibility and Health-economic Evaluation of Remote Clinical Monitoring Enabling Same-day Discharge After Bariatric Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJessa Hospital

About this trial

The ultimate goal of this research is to optimize care for patients undergoing laparoscopic bariatric surgery while alleviating pressure on hospital resources and staff. Furthermore, the study aims to generate policy-relevant data that can inform policymakers and healthcare providers in developing funding models and care pathways that balance safety, efficiency, and cost-effectiveness. This could support a broader implementation of ambulatory bariatric surgery without compromising quality of care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-65 years old

Undergoing scheduled ambulatory Roux en Y Gastric Bypass

ASA score I or II

Competent to provide informed consent

Disqualifiers

Presence of coagulation abnormalities or use of anticoagulant therapy

History of major abdominal surgeries, including laparotomy

Absence of informed consent or request not to participate in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • remote clinical monitoring

    Device

    Remote clinical monitoring after same day discharge

  • Control group

    Other intervention

    Control group with overnight stay in hospital

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Remote clinical monitoringExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of same day discharge with a remote monitoring pathway

The primary outcome of this study is to assess the feasibility of a SDD care pathway with remote monitoring for patients undergoing laparoscopic RYGB in an ambulatory setting.

Time frame
throughout completion of the study, an average of one year
2

cost-effectiveness analysis

). The CEA will result in an incremental cost-effectiveness ratio (ICER), which is the ratio of the incremental costs of the remote monitoring program to incremental health gains of the program compared to the standard care. The analysis will be performed from a societal perspective, meaning that all relevant costs will be included, irrespective of who pays for the costs (patient, hospital, or RIZIV).

Time frame
throughout completion of the study, an average of one year

Secondary outcomes

1

Clinical safety- complications

Postoperative complications will be classified using the Clavien-Dindo classification system and assessed up to 3 months postoperatively.

Time frame
throughouth the study, an average 3 months after surgery
2

• Patient Quality of Life

o Evaluated using the EQ-5D questionnaires. * In the intervention group, patients will receive these questionnaires digitally through the BeWell application. The frequency of questionnaire administration will be increased to daily during the first 7 postoperative days, and subsequently at 2 weeks, 1 month, 6 weeks, 2 months, and 3 months after surgery (17,18). * In the control group, questionnaires will be administered in person during their hospital stay or by telephone after discharge. Questionnaires will be administered at 1 day, 7 days, 1 month, 2 months, and 3 months after surgery.

Time frame
throughout completion of the study, up to 3 months after surgery
3

• Patient Satisfaction

Patient Satisfaction will be measured after 3 months using a 7-point Likert scale and 11-point Numeric Rating Scale (NRS 0-10) to assess satisfaction with the care pathway, feelings of safety, and sufficiency of recovery advice/follow-up information

Time frame
throughout the completion of the study, 3 months after surgery
4

Length of stay

o Duration of Hospital Stay: The total number of hours from surgery to discharge will be recorded, with hospital admission and discharge data systematically collected for both groups.

Time frame
throughout hospital stay, an average from 0 to 2 days after surgery

Other outcomes

Sponsors and contacts

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